Alteogen's Tergase® (Novel Recombinant Human Hyaluronidase Injection) Shows Excellent Immunogenicity Profile

2023-09-05

临床结果上市批准

Alteogen expects Tergase® will replace commercially available animal-derived hyaluronidase products and their significant disadvantages. Compared with other commercially available hyaluronidase products,

Tergase® showed no incidence of anti-drug antibodies (ADA). The occurrence of ADA is known to adversely affect the safety and efficacy of a drug.

DAEJEON, South Korea, Sept. 5, 2023 /PRNewswire/ -- Alteogen Inc. (KOSDAQ:196170), a Korean biotech company announced that their recently concluded clinical trial of Tergase® showed zero incidence of ADA (including neutralizing antibodies). Tergase® is Alteogen's first proprietary product currently under pharmaceutical approval process by the Korean Ministry of Food and Drug Safety.

Tergase® is a stand-alone hyaluronidase product that can be used for the treatment of various medical conditions, such as pain relief, edema treatment, and hyaluronic acid filler removal. In particular, compared to commercially available animal-derived hyaluronidase products in the market, it is a highly purified product of high-quality with very few impurities and an excellent side effect profile. As a Novel Recombinant Human Hyaluronidase, Alteogen expects that Tergase® will be applicable to new indications which are currently not available to existing animal-derived products.

The presence of ADA is known to induce unwanted side effects. Therefore, regulatory authorities have very closely scrutinized products for the presence of ADA, using data from immunogenicity safety studies. ADA are also intimately related to drug efficacy and duration of drug action. As Tergase® is a genetically modified human recombinant protein generated by domain swapping technology between two subtypes of human hyaluronidases, the low incidence of ADA was expected. Thus, Alteogen believes the outcome of zero ADA incidence in the clinical trial with 244 healthy volunteers make Tergase® a highly competitive product in the market due to its high quality.

Dr. Soon Jae Park, CEO of Alteogen said, "we believe that in this market, there is a strong need for differentiated products, from the stability and safety perspective, since existing animal-derived products cannot be widely used due to their side effect profiles. When compared with the one and only commercially available human recombinant hyaluronidase from Alteogen's competitor, Tergase® may be superior in many aspects and we expect this will help us gain significant market share in various fields."

Previously, literature review showed 3~12% ADA incidence in the competitor's recombinant hyaluronidase product. Even more impressive is that a 4~20 fold more dosing of Tergase®, compared with dosage used for the competitor's product, resulted in significantly less ISR (Injection Site Reactions) occurrence.

Currently, Tergase® is undergoing pharmaceutical approval process by the Ministry of Food and Drug Safety, and it is expected to obtain product approval between the end of 2023 and the beginning of 2024 at the latest, depending on the schedule for additional supplementary data requirement.

About Alteogen Inc.

Alteogen Inc. is a South Korea-based biopharmaceutical company that focuses on the development and commercialization of novel biologics such as Antibody-Drug Conjugates (ADCs), biobetters, and biosimilars. Alteogen's portfolio includes clinical-stage long-acting therapeutic proteins and next-generation ADCs, developed by its proprietary NexP™-fusion and NexMab™ platform technology, respectively. It also developed a proprietary recombinant human hyaluronidase enzyme utilizing Hybrozyme™ technology, which enables the large volume subcutaneous administration of drugs that are typically administered as an IV injection. The company was founded in 2008 and listed in KOSDAQ (196170.KQ).

Contacts

US: Vivek Shenoy, Ph.D., MBA

Chief Business Officer

Phone: +18055708998

E-mail: [email protected]

ROW: Tae-Yon Chun, Ph.D., J.D.

Corporate Alliance Officer

Phone: +820428678861

E-mail: [email protected]

SOURCE Alteogen Inc.

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